PharmOut

To supplement the draft guidance for industry on Request for Quality Metrics, The US FDA have released a Quality Metrics Technical Conformance Guide to recommend how quality data should be submitted. The document contains …

Within the last 30 days, the US FDA released two new Warning Letters and yes-you guessed it, all contain data integrity violations. Lets look them below:
Falsifying test data from a stability batch
The latest Warning Letter is …

Are you innovative?
We have too many people sitting about complaining about our shrinking Australian manufacturing industry, but you can do something about it! I have always believed that you must build in quality. For example …

The review of data is the basis of everything that we do in the industry. It is the foundation of regulatory filings, controls in manufacturing, the checks in laboratory analysis, assurance of product release …

This very practical question seems to be on everyone’s lips, ‘ISO 13485 2016 is here, what do we do now?’
With a three year transition period proposed (N233 Draft White Paper – ISO Transition Planning …